Olaparib Oral capsule

What is this medicine?

OLAPARIB (oh LA pa rib) is a chemotherapy drug. It targets specific enzymes within cancer cells and stops the cancer cell from growing. This medicine is used to treat ovarian cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• anemia

• kidney disease

• liver disease

• lung disease

• low blood counts, like low white cell, platelet, or red cell counts

• an unusual or allergic reaction to olaparib, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew this medicine. You may take it with food. However, avoid grapefruit juice, grapefruit or Seville oranges while on this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• antiviral medicines for hepatitis, HIV or AIDS

• aprepitant

• boceprevir

• bosentan

• carbamazepine

• certain medicines for fungal infections like fluconazole, ketoconazole, itraconazole, posaconazole, and voriconazole

• certain medicines for infections, such as ciprofloxacin, clarithromycin, erythromycin,telithromycin

• crizotinib

• diltiazem

• grapefruit juice

• imatinib

• modafinil

• nafcillin

• nefazodone

• phenobarbital

• phenytoin

• rifampin

• Seville oranges

• St. John's Wort

• telaprevir

• verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop. You will need blood work done while you are taking this medicine.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

If you are going to have surgery or any other procedures, tell your doctor you are taking this medicine.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Women who are able to become pregnant should use effective birth control during treatment and for at least 1 month after receiving the last dose. Talk to your healthcare provider about birth control methods that may be right for you. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems, like shortness of breath, cough, or wheezing

• fever

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose

• signs and symptoms of a blood clot such as changes in vision; chest pain with breathing problems; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm or leg

• signs and symptoms of low magnesium like muscle cramps or muscle pain; tingling or tremors; muscle weakness; seizures; or fast, irregular heartbeat

• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine

• weak or tired

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• changes in taste

• diarrhea

• headache

• heartburn, indigestion

• loss of appetite

• muscle or joint pain

• nausea/vomiting

• runny nose

• stomach pain

• weight loss

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Do not store at temperatures greater than 40 degrees C (104 degrees F) and do not take this medicine if you think it may have been stored at a temperature greater than 104 degrees F. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.